: Public <<DEPRECATED>> Class
Created: 1/11/2006 9:35:26 AM
Modified: 8/26/2017 2:46:28 AM
Project:
Advanced:
DEFINITION:<br/>A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision. <br/><br/>EXAMPLE(S):<br/>A request for approval to either market a product or to allow the applicant to start testing of a proposed product.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness.<br/><br/>Submissions are always associated with some regulatory action (or inaction). Each submission contains their own regulatory action. Submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units.<br/><br/>Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. <br/>
Attribute
Public CD
  typeCode
Details:
Map:CTRRr3=Submission.typeCode
Map:CTRv1.0=Submission.typeCode
Map:RPS1=Submission.type
Notes: DEFINITION:<br/>A coded value specifying the kind of submission.<br/><br/>EXAMPLE(S):<br/>original, supplement, annual report<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public TS.DATETIME
  receiptDate
Details:
Map:CTR&Rr2=NCA Submission Date
Map:CTR&Rr2=IEC Submission Date
Map:CTRRr3=Submission.receiptDate
Map:CTRv1.0=Submission.receiptDate
Map:RPS1=Submission.receiptDate
Notes: DEFINITION:<br/>The date (and time) on which the first submission unit is received by the regulatory authority. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from the transmission of the first SubmissionUnit to a RegulatoryAuthority. The first transmission is a new SubmissionUnit, Submission and RegulatoryApplication. The first submission of a SubmissionUnit starts a regulatory clock and that is how Submission.receiptDate is derived. Subsequent SubmissionUnits are considered either amendments or supplements to the Submission and/or RegulatoryApplication and the dates for those SubmissionUnits are for tracking purposes and do not set the regulatory time clock. <br/>
Public CD
  statusCode
Details:
Map:CTR&Rr2=GMP MP Auth pending
Map:CTR&Rr2=IEC Opinion Status
Map:CTRv1.0=Submission.statusCode
Map:ICSRr2=Approval.statusCode (in R_Product)
Map:RPS1=Submission.status
Notes: DEFINITION:<br/>A coded value specifying the phase in the lifecycle of the submission. <br/><br/>EXAMPLE(S):<br/>active, withdrawn<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Please refer to the Submission Status state transition diagram for further details.<br/>
Public TS.DATETIME
  statusDate
Details:
Map:CTRv1.0=Submission.statusDate
Map:RPS1=Submission.status
Notes: DEFINITION:<br/>The date (and time) on which the status is assigned to the submission.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
«DEPRECATED» RegulatoryApplicationSponsor
Class   		Name: submittedSubmission
  		Name: submittingRegulatoryApplicationSponsor
 
Details:
DESCRIPTION:<br/>Each Submission always is submitted by one RegulatoryApplicationSponsor.  Each RegulatoryApplicationSponsor always submits one or more Submission.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
«DEPRECATED» RegulatoryAssessment
Class   		Name: evaluatedSubmission
  		Name: evaluatingRegulatoryAssessment
 
Details:
DESCRIPTION:<br/>Each Submission might be evaluated in one RegulatoryAssessment. Each RegulatoryAssessment always evaluates one or more Submission.  <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
«DEPRECATED» RegulatoryApplication
Class   		Name: groupedSubmission
  		Name: groupingRegulatoryApplication
 
Details:
DESCRIPTION:<br/>Each Submission always is grouped by one RegulatoryApplication. Each RegulatoryApplication always groups one or more Submission. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Product
Class   		Name: describingSubmission
  		Name: describedProduct
 
Details:
DESCRIPTION:<br/>Each Submission always has as subject one Product.  Each Product might be the subject for one or more Submission.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
«DEPRECATED» SubmissionUnit
Class   		Name: groupedSubmissionUnit
  		Name: groupingSubmission
 
Details:
DESCRIPTION:<br/>Each SubmissionUnit might be grouped into one Submission.  Each Submission might group one or more SubmissionUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
«DEPRECATED» ReviewableUnit
Class   		Name: groupedReviewableUnit
  		Name: groupingSubmission
 
Details:
DESCRIPTION:<br/>Each ReviewableUnit always is grouped into one Submission.  Each Submission might group one or more ReviewableUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:CTRRr3 Submission
Details:
 
Map:CTRv1.0 Submission
Details:
 
Map:ICSRr2 replacementOf (in R_Product)
Details:
 
Map:RPS1 Submission
Details:
 
Constraint Type Status
groups Exclusive Or Invariant Approved
Details:
A Submission must have one or more ReviewableUnit or SubmissionUnit but not both.<br/>
has as subject actualIndicator Qualifier Invariant Approved
Details:
Only Product with actualIndicator = "false" is valid.<br/>
Object Type Connection Direction Notes
«DEPRECATED» SubmissionUnit Class Strong From DESCRIPTION: Each SubmissionUnit might be grouped into one Submission. Each Submission might group one or more SubmissionUnit. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
«DEPRECATED» ReviewableUnit Class Strong From DESCRIPTION: Each ReviewableUnit always is grouped into one Submission. Each Submission might group one or more ReviewableUnit. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
«DEPRECATED» RegulatoryApplication Class Strong To DESCRIPTION: Each Submission always is grouped by one RegulatoryApplication. Each RegulatoryApplication always groups one or more Submission. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):